MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-04-26 for TAXO PAPER DIFFERENTIATION DISCS FOR PNEUMOCOCCI 31046 manufactured by Becton Dickinson Microbiology Systems.
[19044]
While opening bottle of discs, bottle broke, causing cut on lefthand thumb. This is the second incident using this product. It appears the tops are too large for the bottle, causing the bottle to break upon opening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4000903 |
| MDR Report Key | 27333 |
| Date Received | 1995-04-26 |
| Date of Event | 1995-04-20 |
| Date Added to Maude | 1995-10-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAXO PAPER DIFFERENTIATION DISCS FOR PNEUMOCOCCI |
| Generic Name | TAXO PAPER DIFFERENTIATION DISCS FOR PNEUMOCOCCI |
| Product Code | JSI |
| Date Received | 1995-04-26 |
| Catalog Number | 31046 |
| Device Expiration Date | 1997-07-01 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 28205 |
| Manufacturer | BECTON DICKINSON MICROBIOLOGY SYSTEMS |
| Manufacturer Address | COCKEYSVILLE MD 21030 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-04-26 |